Device class
Class II
Regulation 878.5030
Total clearances
4
2023-07-31 → 2024-12-03
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.5030
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Shandong Haidike Medical Product Co., Ltd. |
1 |
0 |
2024-01-16 |
|
Huaian Seamen Medical Technology Co., Ltd. |
1 |
0 |
2023-07-31 |
|
Covidien
|
1 |
0 |
2024-12-03 |
|
Safepath Medical, Inc. |
1 |
0 |
2024-10-18 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 99070 |
CPT
|
— |
High
|
Nonabsorbable silk sutures typically billed as surgical supplies |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-12-03 |
K241486 |
Covidien
|
Sofsilk Coated Braided Silk Suture |
| 2024-10-18 |
K222944 |
Safepath Medical, Inc.
|
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture |
| 2024-01-16 |
K232355 |
Shandong Haidike Medical Product Co., Ltd.
|
Non absorbable Surgical Silk Suture |
| 2023-07-31 |
K221767 |
Huaian Seamen Medical Technology Co., Ltd.
|
Surgical Sutures with or without Needle |